安科生物(300009.SZ):參股公司PA3-17注射液治療成人復發/難治性CD7陽性血液淋巴系統惡性腫瘤獲批臨牀
格隆匯8月9日丨安科生物(300009.SZ)公佈,近日,公司參股公司博生吉醫藥科技(蘇州)有限公司(簡稱“博生吉公司”)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,同意博生吉公司開展治療成人復發/難治性CD7陽性血液淋巴系統惡性腫瘤的臨牀試驗。
該次獲得臨牀試驗批准的是博生吉公司自主研發的國際首款基於納米抗體的CD7-CAR-T細胞注射液(研發代號:PA3-17注射液),其適應症為成人復發、難治性CD7陽性血液淋巴系統惡性腫瘤患者。該藥物首次提交臨牀試驗申請獲得受理的時間為2021年5月17日。
CD7陽性的惡性腫瘤大多屬於高侵襲性淋巴瘤或者白血病,病程進展快,預後差,大部分病例化療緩解後短期內就發生復發。這些疾病主要包括:T淋巴母細胞性白血病、淋巴瘤(T-ALL/LBL)、早期前T淋巴母細胞白血病(ETP-ALL)、結外NK/T細胞淋巴瘤,以及多種少見病和罕見病等。
對於難治複發性T-ALL/LBL的治療,國際上僅有美國FDA批准了奈拉濱(nelarabine)作為其治療用藥,在中國並未上市。然而,來自2019年6月歐洲血液學協會(EHA)的最新臨牀Ⅳ期試驗數據顯示,患者接受奈拉濱單藥治療後,1年OS為38%,5年OS為18%,中位數生存時間僅僅8個月,因此難治複發性T-ALL/LBL等適應症代表着臨牀上亟待滿足的需求。
博生吉公司研製的自體CD7-CAR-T細胞,避免了基因編輯的相關風險,再加上體內呈現優越的擴增與持續性,因此療效顯著,安全性較高。
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